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Reuters Health Information (2011-06-03): Renal effect of tenofovir is milder when it's used only for HBV

Drug & Device Development

Renal effect of tenofovir is milder when it's used only for HBV

Last Updated: 2011-06-03 17:02:05 -0400 (Reuters Health)

NEW YORK (Reuters Health) - Monotherapy for hepatitis B virus infection with tenofovir or other polymerase inhibitors affects kidneys only mildly, new research shows.

That's in dramatic contrast to what's been seen when tenofovir is used in antiretroviral combinations for HIV.

"According to our observations all HBV-polymerase inhibitors seem reasonably safe concerning renal function in HBV monotherapy," said lead researcher Dr. Stefan Mauss from the Center for HIV and Hepatogastroenterology, Duesseldorf, Germany, in an email to Reuters Health.

In a study reported online May 19th in the Journal of Hepatology, Dr. Mauss and colleagues used mathematical models to predict yearly median individual changes in renal function with various polymerase inhibitors given as monotherapy for isolated hepatitis B infection. For comparison, they also applied the models to patients with isolated HIV receiving polymerase inhibitor containing combinations.

Glomerular filtration rates (GFR) were derived from serum creatinine measurements. Projected annual changes in GFR were estimated with linear mixed effect models. Baseline renal function was normal in both groups.

The hepatitis B group included 36 patients on lamivudine, 32 on adefovir, 32 on entecavir and 37 on tenofovir monotherapy. Sixty untreated hepatitis B positive patients served as controls. The HIV group included 120 patients receiving tenofovir, 52 receiving zidovudine and not tenofovir, and 109 who were treatment na�ve.

The projected annual decline in GFR in the HBV group was less than 1 ml/min overall, 0.92ml/min with lamivudine or tenofovir, 1.02ml/min with adefovir, and 1.00 ml/min with entecavir. The predicted annual GFR decline was 2.05 ml/min in untreated controls.

In the HIV group, the predicted renal function decline was significantly greater with tenofovir based combinations (2.64 ml/min) than with zidovudine (1.00 ml/min). The predicted GFR decline in untreated patients was similar to the decline with zidovudine.

"Due to the study size this statement accounts only for general drug effects and not rare events," Dr. Mauss said.


J Hepatol 2011.

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